A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- MediciNova
- 入组人数
- 296
- 试验地点
- 28
- 主要终点
- Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)
研究概览
简要总结
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.
详细描述
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in a 1:1:1 ratio to receive either 500 mg MN-001 bid, 500 mg MN-001 once daily or placebo. Patients will be dispensed study drug beginning at Baseline (Visit 2) and will return to the study center for Visit 3 (28 days ± 2 days after Baseline), and Visit 4 (56 days ± 2 days after Baseline), at end of study for safety and efficacy assessments. The patient will be contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. Study drug will be dispensed at Visits 2 and 3. Safety assessments will include adverse events, physical examinations, clinical laboratory testing, and changes in vital signs. Efficacy assessments include percentage of patients at least "moderately improved" for each treatment group using the patient reported Global Response Assessment (GRA) (see Appendix 1). Secondary assessments include a decrease in bladder pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC;
- •Bladder pain ≥ 6 months prior to baseline;
- •Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;
- •Nocturia ≥ 2x/night;
- •Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study:
- •Female patients of child bearing age must have a negative urine pregnancy test at screening;
- •Must provide a signed informed consent.
排除标准
- •Male or females < 18 years of age;
- •Initiation of new IC medication ≤ 30 days prior to baseline;
- •Treatment with Elmiron ≤ 120 days prior to baseline;
- •Treatment with bladder hydro-distention ≤ 6 months prior to baseline;
- •Treatment with intravesical therapy ≤ 60 days prior to baseline;
- •History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or cystolysis) that has affected bladder function;
- •Active genital herpes or vaginitis ≤ 90 days prior to baseline;
- •Urinary tract or prostatic infection ≤ 90 days prior to baseline;
- •History of urethral diverticulum;
- •History of bladder or ureteral calculi;
- •History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis;
- •History of bladder tumors;
- •History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to baseline;
- •Patient is currently pregnant, lactating or likely to become pregnant during the study;
- •Participated in another clinical study with an investigational drug or device ≤ 30 days prior to baseline.
研究组 & 干预措施
MN-001
干预措施: MN-001 BID (Drug)
MN-001
干预措施: MN-001 (Drug)
MN-001 once daily
placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)
时间窗: 8 weeks
The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.
次要结局
- Number of Responders for GRA Assessment in Their Condition at Week 4.(4 weeks)